GMP Documentation Specialist
6 giorni fa
Description
Job Title: GMP Documentation Specialist
Location: Pisa
- Ensure GMP compliance through effective management of production documentation, including critical revision, approval, issuance, and maintenance.
- Develop and execute training programs on production documentation, focusing on strong training efficacy.
- Manage logistics for manufacturing and visual inspection, including preparation and distribution of documentation.
- Identify and address gaps in manufacturing and visual inspection processes.
- Collaborate with regulatory authorities during audits.
- Guarantee data management for trending purposes.
- Manage direct reports involved in production documentation, logistics, deviation management, and process optimization.
- Develop and implement strategies to meet production objectives and ensure compliance.
- Foster a culture of quality and compliance within the team.
- Ensure the security of production documentation and facilities.
Requirements
- Degree in scientific disciplines (Chemistry, Pharmaceutical Technologies, Biology, Biotechnology, Chemistry).
- At least 5 years of experience in pharmaceutical companies, with deep knowledge of aseptic production processes.
- Deep knowledge of GMP regulations and manufacturing of sterile products with RABS and Isolators.
- Good knowledge of English and main IT applications (Word, Excel, PowerPoint). Previous use of Trackwise System.
- Familiarity with digitalization of systems and processes.
- Strong relationship and communication skills, ability to influence others.
- Ability to take independent decisions based on data evaluation and risk assessment.
-
GMP Compliance Documentation Specialist
6 giorni fa
Pisa, Toscana, Italia Takeda Pharmaceutical A tempo pienoAbout the Role:As the Manufacturing Deviation and GMP Documentation Lead, you will oversee the management of all activities related to GMP production documentation. This includes the critical review, approval, issuance, and maintenance of documentation in accordance with GDDP rules and cGMP compliance standards.Key Responsibilities:Guarantee production...
-
Manufacturing Deviation and GMP Documentation Specialist
2 settimane fa
Pisa, Toscana, Italia Takeda A tempo pienoAbout the Role:As the Manufacturing Deviation and GMP Documentation Specialist, you will oversee the management of all activities related to GMP production documentation. This includes the critical review, approval, issuance, and maintenance of documentation in accordance with GDDP rules and cGMP compliance standards. Additionally, you will be responsible...
-
Manufacturing Deviation and GMP Documentation Specialist
1 settimana fa
Pisa, Toscana, Italia Takeda A tempo pienoJob Description:Purpose: We are seeking a highly skilled Manufacturing Deviation and GMP Documentation Specialist to join our team at Takeda. The successful candidate will be responsible for ensuring the management of all activities related to GMP production documentation, including critical revision, approval, issuance, and maintenance according to GDDP...
-
Manufacturing Deviation and GMP Documentation Specialist
1 settimana fa
Pisa, Toscana, Italia Takeda Pharmaceutical A tempo pienoJob Title: Manufacturing Deviation and GMP Documentation LeadWe are seeking a highly skilled Manufacturing Deviation and GMP Documentation Lead to join our team at Takeda Pharmaceutical. As a key member of our quality assurance team, you will be responsible for ensuring the management of all activities related to GMP production documentation, including...
-
Manufacturing Deviation and GMP Documentation Lead
2 settimane fa
Pisa, Toscana, Italia Takeda A tempo pienoJob Title: Manufacturing Deviation and GMP Documentation LeadLocation: PisaAs a key member of our team, you will be responsible for managing all activities related to GMP production documentation, including critical revision, approval, issuance, and maintenance according to GDDP rules and cGMP compliance. You will also be responsible for executing training...
-
Manufacturing Deviation and GMP Documentation Lead
4 settimane fa
Pisa, Toscana, Italia Takeda A tempo pienoJob Title: Manufacturing Deviation and GMP Documentation LeadLocation: PisaJob Summary:We are seeking a highly skilled Manufacturing Deviation and GMP Documentation Lead to join our team at Takeda. As a key member of our production team, you will be responsible for ensuring the management of all activities related to GMP production documentation, including...
-
Manufacturing Deviation and GMP Documentation Lead
2 settimane fa
Pisa, Toscana, Italia Takeda Pharmaceutical A tempo pienoAbout the Role:As the Manufacturing Deviation and GMP Documentation Lead, you will oversee the management of all activities related to GMP production documentation. This includes the critical review, approval, issuance, and maintenance of documentation in accordance with GDDP rules and cGMP compliance standards. Additionally, you will be responsible for...
-
Pisa, Toscana, Italia Takeda A tempo pienoJob Title: Manufacturing Deviation and GMP Documentation LeadLocation: PisaKey Responsibilities:Ensure management of all activities related to GMP production documentation, including critical revision, approval, issuance, and maintenance according to GDDP rules and cGMP compliance.Execute training on production documentation, ensuring strong training...
-
Manufacturing Deviation and GMP Documentation Lead
3 settimane fa
Pisa, Toscana, Italia Takeda A tempo pienoJob Title: Manufacturing Deviation and GMP Documentation LeadLocation: PisaAbout the Role:We are seeking a highly skilled and experienced Manufacturing Deviation and GMP Documentation Lead to join our team at Takeda. As a key member of our production team, you will be responsible for ensuring the management of all activities related to GMP production...
-
Pisa, Toscana, Italia Takeda A tempo pienoJob DescriptionAbout the Role: We are seeking a highly skilled Manufacturing Deviation and GMP Documentation Lead to oversee the management of all activities related to GMP production documentation.Key Responsibilities:Guarantee production documentation critical revision approval, issuance, maintenance (Master Batch Records, SOPs, forms, logbooks, visual...
-
Manufacturing Deviation and GMP Documentation Lead
2 settimane fa
Pisa, Toscana, Italia Takeda A tempo pienoJob Title: Manufacturing Deviation and GMP Documentation LeadLocation: PisaAs a key member of our team, you will be responsible for ensuring the management of all activities related to GMP production documentation, including critical revision, approval, issuance, and maintenance according to GDDP rules and cGMP compliance.Key Responsibilities:Manage the...
-
Pisa, Toscana, Italia Takeda A tempo pienoAbout the Role:Takeda is seeking a highly skilled Manufacturing Deviation and GMP Documentation Lead to join our team in Pisa, Italy.Job Summary:The Manufacturing Deviation and GMP Documentation Lead will be responsible for managing all activities related to GMP production documentation, including critical revision, approval, issuance, and maintenance...
-
Manufacturing Deviation and GMP Documentation Lead
4 settimane fa
Pisa, Toscana, Italia Takeda A tempo pienoAbout the Role:We are seeking a highly skilled Manufacturing Deviation and GMP Documentation Lead to join our team at Takeda. As a key member of our production team, you will be responsible for ensuring the management of all activities related to GMP production documentation, including critical revision, approval, issuance, and maintenance according to GDDP...
-
Production Documentation Specialist
1 settimana fa
Pisa, Toscana, Italia Takeda A tempo pienoPurpose and ScopeThe Production Documentation Specialist will oversee the management of all activities related to production documentation ownership, ensuring cGMP compliance and the execution of related training. This role will be responsible for executing documentation revision, issuance, and maintenance according to GDDP rules.Key ResponsibilitiesExecute...
-
Production Documentation Specialist
4 settimane fa
Pisa, Toscana, Italia Takeda A tempo pienoAbout the Role:Takeda is seeking a highly skilled professional to join our team as a Production Documentation Specialist. In this role, you will be responsible for managing production documentation, including the creation, revision, and issuance of electronic Manufacturing Batch Records and Equipment Specifications. You will also oversee production changes...
-
Production Documentation Specialist
4 settimane fa
Pisa, Toscana, Italia Takeda A tempo pienoAbout the Role:Takeda is seeking a highly skilled professional to join our team as a Production Documentation Specialist. In this role, you will be responsible for managing production documentation, including the creation, revision, and issuance of electronic Manufacturing Batch Records and Equipment Specifications. You will also oversee production changes...
-
Production Documentation Specialist
1 mese fa
Pisa, Toscana, Italia Takeda A tempo pienoAbout the Role:Takeda is seeking a highly skilled professional to join our team as a Production Documentation Specialist. In this role, you will be responsible for managing production documentation, including the creation, revision, and issuance of electronic Manufacturing Batch Records and Equipment Specifications. You will also oversee production changes...
-
Production Documentation Specialist
2 settimane fa
Pisa, Toscana, Italia Takeda Pharmaceutical A tempo pienoAbout the Role:In the realm of production, effective management of documentation is crucial for ensuring compliance and excellence in production standards. As a subject-matter expert, overseeing production changes and conducting related risk assessments is a key responsibility. Moreover, leading projects that enhance production processes and continuous...
-
Production Documentation Management Specialist
1 settimana fa
Pisa, Toscana, Italia Takeda A tempo pienoAbout the Role:In the realm of pharmaceutical production, proper documentation management is crucial for maintaining quality and compliance. As a subject-matter expert, you will oversee production changes, conduct risk assessments, and lead projects to enhance production processes and continuous improvement initiatives.Your Key Responsibilities:Complete and...
-
Production Specialist
6 giorni fa
Pisa, Toscana, Italia Takeda A tempo pienoAbout the Role:Takeda is seeking a highly skilled Production Specialist to oversee production documentation, manage change control, and ensure compliance with GMP regulations. The ideal candidate will have experience in aseptic production and a strong understanding of sterile manufacturing processes.Key Responsibilities:Develop, revise, and approve...
